Madhura Khare, Cytel

Session CD02 - PHUSE 2014 PHUSE 2014 - CD02 1

Findings about “Findings about”

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Any comments or statements made herein are solely those of the author and do not necessarily reflect the views of company.

Disclaimer

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q  Introduction

q  Findings About

ü Intervention

ü Events

q  Examples

q  Summary

q  Discussion/ Questions

Agenda

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General Observation Class

Event Intervention Findings

AE

DS

MH

CE

DV

EX

SU

CM

EG

VS

LB

PC

IE

MB

PE

QS

PP

DA

MS

SC

Most of the observations collected will be represented in one of the General Observation Class.

Introduction

Introduction

What happens if information does not fit into Events or Interventions – e.g. - Reasons for not taking concomitant medications

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q  Gives additional information

q  Is not as suitable to be supplemental qualifier

Introduction

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Use of Findings About Domain

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q  Specialization of Findings general observation class

q  Event or Intervention

q  Vertical Structure

q  Important Variables – ü  --OBJ

ü  --TESTCD

Findings About (FA)

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Intervention / Event

Event as a whole Reportable events that occurred?

Possible Supplemental

Qualifier

Measurements associated, findings domain present?

Possible Findings Domain

Possible Findings About Domain

Y N

Y N

Does not fit into either of the class

No Measurements –

results and units

Steps to go through

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Study Brief eCRF

Usage of Findings About

Annotated eCRF

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Findings about Intervention - CASE1

Vitamin D Usage

Study Brief

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q  PHASE III, Multicenter Study to Compare the Therapeutic Efficacy and Safety in Subjects with kidney disease

q  Vitamin D supplements - one of co-medications along with standard of care

eCRF

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FORM: Reason for no baseline Vitamin D Usage   If not vitamin D, Why? Elevated Serum Calcium

Elevated Serum Phosphorus Elevated Calcium X Phosphorous Not Prescribed Other

q  Do not include information about dose and frequency etc.

q  Different reasons can go in Suppqual variables

q  To utilize information further in Tables/Listings easily

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Usage of Findings About

aCRF

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FORM: Reason for no baseline Vitamin D Usage  

FA.FAORRES

SDTM Data Set Name = FA FA.DOMAIN = ‘FA’

If not vitamin D, Why? Elevated Serum Calcium Elevated Serum Phosphorus

Elevated Calcium X Phosphorous Not Prescribed Other

FA.FATESTCD = ‘REASNTKN’

FA.FAOBJ = ‘VITAMIN D’

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Findings about Intervention - CASE2

Prior Radiotherapy for Current Malignancy

q  Phase I/II, Open - label, Oncology study.

q  Tolerability, safety, pharmacokinetics, and efficacy of study treatment.

q  Prior radio therapy

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Study Brief

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eCRF

Form: Prior Radiotherapy for Current Malignancy TYPE External beam

Brach therapy Total body

Single Beam Start Date   Stop Date

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eCRF

FORM: Prior Radiotherapy for Current Malignancy  Best Response Complete Response

Partial Response Stable Response Progressive Disease Unable to evaluate Not Done  Was chemotherapy part Yes of a concurrent therapy? No Did progression occur? Yes   No Date of Progression

q  Type and start and end date of radiotherapy

q  Best response chemotherapy , progression

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Usage of Findings About

PR domain

Supplemental Qualifier

Dump Significant data

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aCRF

FORM: Prior Radiotherapy for Current Malignancy Best Response Complete Response Partial Response Stable Response Progressive Disease Unable to evaluate ` Not Done Was chemotherapy part of a concurrent Yes therapy? No Did progression occur? Yes   No Date of Progression

FA.FAORRES

FA.FAORRES

FA.FAORRES

FA.FADTC

FA.FATESTCD = ‘BESTRSP’

FA.FATESTCD = ‘CHEMO’

FA.FATESTCD = ‘PRG’

There are multiple pages being mapped to FA domain in this study which is why FACAT is used to categorize those observations

SDTM Data Set Name = FA FA.DOMAIN = ‘FA’

FA.FACAT = ‘HISTORICAL RADIOTHERAPY’

FA.FAOBJ = ‘RADIOTHERAPY’ FA.FAPRESP = ‘Y’

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Data Snapshot

DOMAIN USUBJID PRSPID PRTRT VISIT PRDOSFRM PRPRESP

PR ABC1230101 DAY2-000-018 RADIOTHERAPY DAY2 EXTERNAL

BEAM Y

DOMAIN USUBJID FASPID FATESTCD VISIT FASTRESC FAOBJ FAPRESP

FA ABC1230101 DAY2- 000-018 PRG DAY2 Y RADIOTHERAPY Y

FA ABC1230101 DAY5- 000-010 BESTRSP DAY5 STABLE

DISEASE RADIOTHERAPY Y

Row STUDYID RDOMAIN IDVAR RELTYPE RELID Row

1 ABC PR PRSPID ONE 1 1

2 ABC FA FASPID MANY 1 2

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Findings about Intervention - CASE3

Standard of Care Administration Time on PK Collection Days

q  Phase II, randomized, Oncology study. q  IP or placebo with standard of care

(SOC) in Postmenopausal Women with Metastatic Breast Cancer.

q  Standard of Care (SOC) administration time on PK collection

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Study Brief

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eCRF

FORM : SOC ADMINISTRATION TIME ON PK COLLECTION DAYS

Date and time of SOC administration   Did subject eat a meal within 2 hours prior to SOC

dose?     Did subject vomit within 1 hour after SOC

administration?      

q  Do not describe an Intervention as a whole

q  Intervention on PK collection days has different timing from the rest of the study days

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Usage of Findings About

FORM:SOC ADMINISTRATION TIME ON PK COLLECTION DAYS Date and time of SOC administration

Did subject eat a meal within 2 hours prior to SOC dose?    

Did subject vomit within 1 hour after SOC administration?      

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aCRF

FA.FATESTCD = ‘OCCUR’ FA.FAOBJ = ‘SOC’ FA.FAORRES = ‘Y’ FA.FADTC

FA.FATESTCD = ‘OCCUR’

FA.FATPTREF = ‘PK SOC’

FA.FATESTCD = ‘OCCUR’ FA.FAOBJ = ‘VOMIT’ FA.FAORRES

FA.FAEVLINT = ‘P1H’ FA.FATPTREF = ‘PK SOC’

SDTM Data Set Name = FA FA.DOMAIN = ‘FA’

FA.FACAT = ‘PK’

FA.FAOBJ = ‘MEAL’ FA.FAORRES

FA.FAEVLINT = ‘-P2H’

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Findings about Event- CASE4

Clinical Features of Seizure

q  Phase III, randomized, efficacy and safety study with Chronic Kidney Disease.

q  To compare efficacy of study treatment with placebo for reducing ionized parathyroid (IPTH) levels.

q  Adverse event of interest is SEIZURE

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Study Brief

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eCRF

FORM: CLINICAL FEATURES OF SEIZURE Clinical Features Impairment of Consciousness Associated with Abnormal Motor Activity Seizure Incontinence Accidental Injury

Post-Event Weakness

Clinical features of seizure Only creating 1 Record with --TERM as SEIZURE

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Usage of Findings About

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aCRF

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FA.FAOBJ FA.FAORRES = ‘Y’

FA.FATESTCD = ‘OCCUR’

FORM: CLINICAL FEATURES OF SEIZURE SDMT Data Set Name = FA FA.DOMAIN = ‘FA’

FA.FACAT = ‘SEIZURE CLINICAL FEATURES’ FA.FAPRESP = ‘Y’

FORM: CLINICAL FEATURES OF SEIZURE

Post-Event Weakness

Abnormal Motor Activity

Incontinence Accidental Injury

Impairment of Consciousness

Clinical Features Associated with Seizure -

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Special Case CASE5

Cosmetic Product Trial

q  Cosmetic trial - can stimulate the skin to result in clinically visible differences, as far as whiteness is concerned

q  Spots on face or chin were exposed q  Objective : Increased whiteness q  Fairness is measured using Chroma –

meter q  L*Intensity

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Study Brief

Data Snapshot

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DOMAIN USUBJID SRSEQ SRTESTCD SRTEST SROBJ SRORRES SRLOC VISITNUM

SR 33444- 101010  1  LINTN LSTAR

INTENSITY CP1 56.71 FORE HEAD 1

q  Skin Response data

q  Study - Cosmetic – many cosmetic product

q  SROBJ – cosmetic product name

q  Recently added to SDTMIG version 3.2

q  Observations about events or interventions that cannot fit into standard domain

q  It’s a solution to map data that cannot be handled by supplemental qualifiers

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Summary

q  Use is rare but its importance is

prodigious.

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Summary

q  CDISC SDTM Implementation Guide Version 3.1.3 and 3.2

q  http://www.cdisc.org/

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References

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